At what age can a child be started on sertraline (selective serotonin reuptake inhibitor)?

Minimum Age for Starting Sertraline

Sertraline can be started as young as 6 years old for obsessive-compulsive disorder, which is the only FDA-approved pediatric indication, though it is commonly used off-label for anxiety disorders in children aged 6-18 years. 1

FDA-Approved Age and Indication

• The FDA has approved sertraline for pediatric patients starting at age 6 years, but only for obsessive-compulsive disorder (OCD). 1
• Safety and effectiveness in pediatric populations other than OCD have not been formally established by the FDA, though extensive clinical trial data supports broader use. 1
• Approximately 600 pediatric patients between ages 6-17 years have received sertraline in clinical trials for both OCD and major depressive disorder, with a safety profile generally similar to adults. 1

Guideline-Supported Age Range for Anxiety Disorders

• The American Academy of Child and Adolescent Psychiatry supports using SSRIs, including sertraline, in children aged 6-18 years for social anxiety, generalized anxiety, separation anxiety, and panic disorder, even though this represents off-label use. 2
• The Child-Adolescent Anxiety Multimodal Study (CAMS) demonstrated that combination CBT plus sertraline improved anxiety symptoms, global function, and remission rates compared to either treatment alone in patients aged 7-17 years. 2

Age-Specific Dosing Considerations

For children ages 6-12 years:

• Start with 25 mg once daily for the first week. 1
• After one week, increase to 50 mg once daily if tolerated. 1
• Maximum dose is 200 mg/day, though lower body weights in children should be considered to avoid excess dosing. 1

For adolescents ages 13-17 years:

• Start with 50 mg once daily. 1
• Can titrate up to 200 mg/day based on response. 1

Critical Safety Monitoring in Young Patients

• All SSRIs, including sertraline, carry a black box warning for suicidal thinking and behavior through age 24 years, with pooled absolute rates of 1% for antidepressants versus 0.2% for placebo (number needed to harm of 143). 2
• Close monitoring for suicidality is essential, especially in the first months of treatment and following dose adjustments. 2
• Behavioral activation/agitation (motor restlessness, insomnia, impulsiveness, disinhibited behavior, aggression) is more common in younger children than adolescents, supporting the need for slow up-titration and close monitoring particularly in the 6-12 year age group. 2

Pharmacokinetic Evidence Supporting Age 6 as Minimum

• Sertraline pharmacokinetics were evaluated in 61 pediatric patients aged 6-17 years and revealed similar drug exposures to adults when adjusted for body weight. 1
• A multicenter study of 187 patients aged 6-17 years demonstrated that sertraline can be safely administered using the adult titration schedule, with mean area under the curve and peak concentrations similar to adult values when normalized for body weight. 3

Important Clinical Caveats

• Parental oversight of medication regimens is paramount in all pediatric patients. 2
• Given sertraline's 24-hour elimination half-life, dose changes should not occur at intervals less than 1 week. 1
• At low doses of sertraline, children may require twice-daily dosing due to shorter effective half-life in some pediatric patients. 2
• Weight loss has been observed in pediatric patients, with approximately 7% of children (versus 2% of adolescents) experiencing weight loss >7% of body weight in clinical trials. 1
• Clinical improvement typically occurs by week 6, with maximal improvement by week 12 or later, so adequate trial duration is essential before declaring treatment failure. 2, 4